Advagraf
Authorised
This medicine is authorised for use in the European Union
tacrolimus
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Advagraf is a medicine used in adults who have had a kidney or liver transplant, to prevent rejection (when the immune system, the body’s natural defences, attacks the transplanted organ). Advagraf can also be used to treat organ rejection in adults when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Advagraf contains the active substance tacrolimus.
Advagraf is available as prolonged-release capsules, which slowly release tacrolimus over several hours. It is taken once a day in the morning, on an empty stomach or at least 1 hour before or 2 to 3 hours after food. The dose of Advagraf is calculated based on the patient’s weight, the type of transplant and whether it’s used to prevent the rejection of the new organ or to treat it. The dose is adjusted according to the patient’s response and the level of medicine in the blood.
Advagraf can only be obtained with a prescription. Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe Advagraf and make changes to immunosuppressive treatment.
For more information about using Advagraf, see the package leaflet or contact your doctor or pharmacist.
The active substance in Advagraf, tacrolimus, is an immunosuppressant. It reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).
Tacrolimus has been used since the mid-1990s. In the EU, it was first available as capsules under the name Prograf or Prograft (depending on the country). The company presented the results of studies that were previously carried out with Prograf/Prograft, as well as information from the published literature.
It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/Prograft or ciclosporin (another immunosuppressive medicine used to prevent rejection). All of the patients were also given the immunosuppressive medicine mycophenolate mofetil. The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year’s treatment. Advagraf was as effective as both comparator medicines. After one year, 14% of the patients receiving Advagraf had experienced organ failure (30 out of 214), compared with 15% in the patients treated with Prograf/Prograft (32 out of 212) and 17% in those treated with ciclosporin (36 out of 212).
Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf taken once a day is absorbed by the body in comparison with Prograf/Prograft taken twice a day. These studies showed that Advagraf and Prograf/Prograft produce similar levels of tacrolimus in the body.
Studies carried out with Advagraf are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Advagraf, see the package leaflet.
The most common side effects with Advagraf (which may affect more than 1 in 10 people) include tremor (shaking), renal impairment (kidney problems), hyperglycaemia (high blood glucose levels), diabetes, hyperkalaemia (high blood potassium levels), infections, hypertension (high blood pressure) and insomnia (difficulty sleeping).
Advagraf must not be used in people who are hypersensitive (allergic) to macrolide antibiotics (such as erythromycin).
The European Medicines Agency decided that Advagraf’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advagraf have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Advagraf are continuously monitored. Side effects reported with Advagraf are carefully evaluated and any necessary action taken to protect patients.
Advagraf received a marketing authorisation valid throughout the EU on 23 April 2007.
Product information
Latest procedure affecting product information:PSUSA/00002839/202403
12/02/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Advagraf
- Active substance
- tacrolimus
- International non-proprietary name (INN) or common name
- tacrolimus
- Therapeutic area (MeSH)
- Graft Rejection
- Anatomical therapeutic chemical (ATC) code
- L04AD02
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
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